Federal Register / Vol. 77, No. 28 / Friday, February 10, 2012 / Rules and Regulations 6971

DEPARTMENT OF HEALTH AND notice of proposed rulemaking Disease Control and Prevention, 1600 HUMAN SERVICES published elsewhere in this issue of the Clifton Road NE., Mailstop E–03, Federal Register. A significant adverse , Georgia 30333; telephone 404– 42 CFR Part 71 comment is one that explains: Why the 498–1600. For information concerning [Docket No. CDC–2012–0003] direct final rule is inappropriate, program operations: Dr. Robert Mullan, including challenges to the rule’s Centers for Disease Control and RIN 0920–AA47 underlying premise or approach; or why Prevention, 1600 Clifton Road NE., the direct final rule will be ineffective Mailstop E–03, Atlanta, Georgia 30333; Establishment of User Fees for or unacceptable without a change. Filovirus Testing of Nonhuman Primate telephone 404–498–1600. DATES: The direct final rule is effective Liver Samples on March 12, 2012 unless significant SUPPLEMENTARY INFORMATION: AGENCY: Centers for Disease Control and adverse comment is received by April This preamble is organized as follows: Prevention (CDC), Department of Health 10, 2012. If we receive no significant I. Public Participation and Human Services (HHS). adverse comment within the specified II. Background ACTION: Direct final rule and request for comment period, we intend to publish III. Rationale for Direct Final Rule comments. a notice confirming the effective date of IV. User Fees the final rule in the Federal Register V. Services and Activities Covered by User SUMMARY: Through this Direct Final within 30 days after the end of the Fees Rule, the Centers for Disease Control comment period on this direct final VI. Analysis of User Fee Charge (Cost to and Prevention (CDC), located within rule. If we receive any timely significant Government) the Department of Health and Human adverse comment, we will withdraw VII. Payment Instructions Services (HHS) is establishing a user fee this final rule in part or in whole by VIII. Regulatory Analysis for filovirus testing of all nonhuman publication of a notice in the Federal IX. References primates that die during HHS/CDC- Register within 30 days after the required 31-day quarantine period for comment period ends. I. Public Participation any reason other than trauma. We are ADDRESSES: You may submit comments, Interested persons are invited to amending regulations to establish a identified by ‘‘RIN 0920–AA47’’: by any participate in this rulemaking by filovirus testing service at HHS/CDC of the following methods: submitting written views, opinions, because testing is no longer being • Internet: Access the Federal e- recommendations, and data. Comments offered by the only private, commercial rulemaking portal at http:// laboratory that previously performed www.regulations.gov. Follow the received, including attachments and these tests. This testing service will be instructions for submitting comments. other supporting materials, are part of funded through user fees. The direct • Mail: Division of Global Migration the public record and subject to public final rule does not impose any new and Quarantine, Centers for Disease disclosure. Do not include any burdens on the regulated community Control and Prevention, 1600 Clifton information in your comment or because the testing of non-human Road NE., MS–03, Atlanta, Georgia supporting materials that you do not primates for filovirus is a long-standing 30333, ATTN: NHP DFR. wish to be disclosed publicly. requirement and the amount of the user Instructions: All submissions received Comments are invited on any topic fee is consistent with the amount must include the agency name and related to this direct final rule. previously charged commercially. HHS/ docket number or Regulation Identifier II. Background CDC is therefore publishing a direct Number (RIN) for this rulemaking. All final rule because it does not expect to comments will be posted without Filoviruses belong to a family of receive any significant adverse comment change to http://regulations.gov, viruses known to cause severe and believes that the establishment of including any personal information hemorrhagic fever in humans and an HHS/CDC testing program and provided. For detailed instructions on nonhuman primates (NHPs). So far, only submitting comments and additional imposition of user fees are non- two members of this virus family have information on the rulemaking process, controversial. However, in this Federal been identified: virus and Register, HHS/CDC is simultaneously see the ‘‘Public Participation’’ heading virus. Five species of Ebola publishing a companion notice of of the SUPPLEMENTARY INFORMATION virus have been acknowledged: Zaire, proposed rulemaking that proposes section of this document. identical filovirus testing and user fee Docket: For access to the docket to Sudan, Reston, Ivory Coast, and requirements. If HHS/CDC does not read background documents or Bundibugyo. Most strains of Ebola virus receive any significant adverse comment comments received, please go to can be highly fatal in humans, and on this direct final rule within the http://www.regulations.gov. Comments while the Reston strain is the only strain specified comment period, it will will be available for public inspection of filovirus that has not been reported to publish a notice in the Federal Register Monday through Friday, except for legal cause disease in humans, it can be fatal confirming the effective date of this holidays, from 9 a.m. until 5 p.m., in monkeys. (http://www.cdc.gov/ final rule within 30 days after the Eastern Time, at 1600 Clifton Road NE., ncidod/dvrd/spb/mnpages/dispages/ comment period on the direct final rule Atlanta, Georgia 30333. Please call filoviruses.htm). ends and withdraw the notice of ahead to 1–866–694–4867 and ask for a Ebola hemorrhagic fever was first proposed rulemaking. If HHS/CDC representative in the Division of Global recognized in 1976, when two receives any timely significant adverse Migration and Quarantine (DGMQ) to epidemics occurred in southern Sudan schedule your visit. To download an comment, it will withdraw the direct and in Zaire. Since that time, multiple electronic version of the rule, access final rule in part or in whole by outbreaks have occurred, mostly in http://www.regulations.gov. publication of a document in the Central , and all have been FOR FURTHER INFORMATION CONTACT: Federal Register within 30 days after For associated with high (45–90%) case- the comment period ends and proceed questions concerning this direct final fatality rates in humans (for an updated with notice and comment under the rule: Ashley A. Marrone, JD, Centers for

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list see http://www.cdc.gov/ncidod/ As a result, on April 20, 1990, HHS/ caretakers (4). Since the implementation dvrd/spb/mnpages/dispages/ebola/ CDC published a notice in the Federal and strengthening of the 1990 special- ebolatable.htm). In these epidemics, Register requiring a special-permit for permit requirements for importing transmission of the disease originated or importing cynomolgus, African green, nonhuman primates into the United occurred in a hospital (often by and rhesus monkeys (5). To be granted States, the morbidity and mortality of contaminated needles) and was a special-permit, importers must submit imported animals has decreased from an followed by person-to-person a plan to HHS/CDC describing specific estimated 20% to less than 1% (10). transmission by individuals who were isolation, quarantine, and Since 1990, these laboratory tests have exposed to, or had close contact with communicable disease control been conducted by a single commercial blood or secretions from seriously ill measures. The plan must detail the laboratory. Recently, a number of patients. measures to be carried out at every step circumstances have arisen such that this The ecology, natural history, and of the chain of custody, from laboratory is no longer able to perform mode of transmission of Ebola virus in embarkation at the country of origin, the testing for filovirus required on liver nature, and of the related , through delivery of the NHPs to the specimens from monkeys that die are becoming more clearly understood quarantine facility and the completion during the HHS/CDC-mandated with the implication of bats as of the required quarantine period. quarantine. Further, HHS/CDC notes reservoirs. The incubation period for Additional requirements include that the reagents required for this testing Ebola disease is 5–9 days (range: 2–15 detailed testing procedures for all are not commercially available and days) but can be shorter with parenteral quarantined NHPs to rule out the production of the reagents requires a transmission. Disease onset is abrupt possibility of filovirus infection. When biosafety level 4 laboratory (BSL–4). A and characterized by severe malaise, importers demonstrate compliance with BSL–4 laboratory is also required during headache, high fever, myalgia, joint these special-permit requirements, part of the testing procedure. To our pains, and sore throat. The progression HHS/CDC authorizes continued knowledge, neither commercial entities is rapid and includes pharyngitis, shipments under the same permit for a nor Federal laboratories other than those conjunctivitis, diarrhea, abdominal period of 180 days. Certain components at HHS/CDC are planning to offer this pain, and occasionally facial edema and of the special-permit requirement have service. Because HHS/CDC has the jaundice. Severe thrombocytopenia can changed slightly in response to required laboratory facility, access to the occur, with hemorrhagic manifestations surveillance findings and the reagents, and experienced personnel, it ranging from petechiae to frank development of improved laboratory has started performing this testing when bleeding. Death occurs primarily as a tests. As indicated in the 1990 notice, required and in the absence of a viable result of multi-organ failures. There is importers were informed of these alternative. changes by letter from HHS/CDC (6). no specific therapy, and patient III. Rationale for Direct Final Rule management is usually limited to The current special-permit notice requires filovirus antigen-detection Through this Direct Final Rule (DFR), supportive measures. The disease in HHS/CDC is establishing a user fee to nonhuman primates is very similar to testing on liver specimens from any NHP that dies during quarantine for reimburse HHS/CDC for the costs that in humans, with a very high incurred performing these tests. Upon mortality. reasons other than trauma (7, 8). Antibody testing is also required on the effective date, every NHP quarantine On January 19, 1990, in response to surviving NHPs that exhibit signs of facility will be contacted by HHS/CDC’s the identification of Ebola- possible filovirus infection before the Division of Global Migration and in NHPs imported from the Philippines, cohort is released from quarantine (9). Quarantine (DGMQ), and will be HHS/CDC published interim guidelines Since October 10, 1975, HHS/CDC has instructed how to transfer tissue for handling NHPs during transit and prohibited the importation of NHPs specimens to HHS/CDC for testing. After also during quarantine (1). Importers of except for scientific, educational, or receipt of the specimens, HHS/CDC will NHPs were informed by letter from the exhibition purposes. Over time, various process the specimens in its BSL–4 HHS/CDC Director on March 15, 1990, measures (e.g., reports, letters, laboratory and test the specimens by an that they must comply with specific guidelines, notices), have been used to antigen-detection enzyme-linked isolation and quarantine standards support implementation of these immunosorbant assay (ELISA) or other under 42 CFR part 71 for continued regulations. On January 5, 2011 (76 FR appropriate methodology. Each registration as an importer of NHPs (2). 678), HHS/CDC posted a Notice of specimen will be held for six months. On March 23, 1990, HHS/CDC held a Proposed Rulemaking (NPRM) to begin After six months, the specimen will be meeting at CDC headquarters in Atlanta, the process of revising these disposed of following established HHS/ Georgia, at which the public could requirements. The NPRM was intended CDC protocol. Based on information comment on new guidelines for the to solicit public comment and feedback supplied by the commercial laboratory, importation of NHPs and the potential on the issue of NHP importation to HHS/CDC estimates that between 100 impact of a temporary ban on the determine the need for further and 150 specimens per year are importation of cynomolgus monkeys rulemaking. Please see the docket expected to be received and tested. into the United States (3). After details for HHS–OS–2011–0002 on Results will be provided to the NHP considering information received at this www.Regulations.gov, for more importers. If a positive test result is public meeting, coupled with an April information. The public comment found, HHS/CDC will ensure that the 4, 1990 confirmation of asymptomatic period ended on April 25, 2011. HHS/ NHP cohort is not released from HHS/ Ebola virus infection in four NHP CDC is now working toward finalizing CDC required quarantine until the caretakers and serologic findings the proposed rule and is not seeking health status of the full cohort is suggesting that cynomolgus, African additional comment on the NPRM determined. This testing protocol will green, and rhesus monkeys posed a risk through this rulemaking. be maintained until further notice. for human filovirus infection, HHS/CDC Laboratory testing of suspected NHPs HHS/CDC has chosen to publish a concluded that these three species were and early detection of infected animals Direct Final Rule (DFR) because we capable of being an animal host or within the quarantine period prevents view this as a non-controversial action vector of human disease (4). spread of disease among NHPs and and anticipate no significant adverse

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comment. This DFR does not create any derived from Federal activities beyond 2012, Public Law 112–74, 125 Stat. additional requirements or burden upon those received by the general public.’’ 1069, 1070 (2011). the regulated community. A significant The Circular gives three examples of adverse comment is one that explains: when the special benefit is considered V. Services and Activities Covered by (1) Why the direct final rule is to accrue, including when a User Fee inappropriate, including challenges to Government service: (a) Enables the HHS/CDC is establishing a user fee to the rule’s underlying premise or beneficiary to obtain more immediate or recoup the costs associated with approach; or (2) why the direct final substantial gains or values (which may performing the required testing. The rule will be ineffective or unacceptable or may not be measurable in monetary user fee will cover the costs of the test without a change. In determining terms) than those that accrue to the for filovirus for specimens submitted to whether a comment necessitates general public (e.g., receiving a patent, HHS/CDC. The following is a list of withdrawal of this direct final rule, insurance, or guarantee provision, or a services and activities that are covered HHS/CDC will consider whether it license to carry on a specific activity or by the user fee: warrants a substantive response in a business or various kinds of public land notice and comment process. If we use); or (b) provides business stability or • Providing information to the receive significant adverse comment on contributes to public confidence in the participants about the service, including this direct final rule, we will publish a business activity of the beneficiary (e.g., instructions on submission of samples timely withdrawal in the Federal insuring deposits in commercial banks); and payment; Register informing the public that the or (c) is performed at the request of, or • Receiving payment and maintaining amendment in this rule will not take for the convenience of, the recipient, account, including distributing funds; effect. If this DFR is withdrawn, we will and is beyond the services regularly • address all public comments in any received by other members of the same Tracking the shipment to ensure a subsequent final rule based on the industry or group or by the general safe arrival at HHS/CDC; Notice of Proposed Rulemaking which public (e.g., receiving a passport, visa, • Providing reagents for and is published simultaneously in the airman’s certificate, or a Customs performing the antigen-detection test on Federal Register. inspection after regular duty hours). submitted NHP liver samples in a BSL– Nothing in this DFR is intended to The Circular sets forth guidelines for 4, high-containment facility; prohibit a private sector facility from determining the amount of user charges • Performing all provided services in developing the capability and offering to assess. When the Government is accordance with industry standards, this same service in the future. The acting in its sovereign capacity, user including quality assurance, handling testing of non-human primate samples charges should be sufficient to cover the and processing procedures, and is necessary to prevent and control a full cost to the Federal Government of hazardous medical waste guidelines; potential outbreak of a filovirus providing the service, resource, or good. and infection in imported monkeys and to The Circular sets forth criteria for • Ensuring that the importer receives prevent the potential spread of determining full cost. ‘‘Full cost the test results in a timely manner. filoviruses to humans. includes all direct and indirect costs to IV. User Fees any part of the Federal Government of VI. Analysis of User Fee Charge (Cost providing a good, resource, or service.’’ to the Government) Title V of the Independent Offices Examples of these types of costs Appropriation Act of 1952 (31 U.S.C. include, but are not limited to, direct HHS/CDC’s analysis of costs to the 9701) (‘‘IOAA’’) provides general and indirect personnel costs, including Government is based on the current authority to Federal agencies to salaries and fringe benefits; physical methodology (ELISA) used to test NHP establish user fees through regulations. overhead, consulting, and other indirect liver samples. This cost determines the The IOAA sets parameters for any fee costs, including material and supply amount of the user fee. HHS/CDC notes charged under its authority. Each charge costs, utilities, insurance, travel, and that the use of a different methodology shall be: rents; management and supervisory or changes in the availability of ELISA (1) Fair; and costs; and the costs of enforcement, reagents will affect the amount of the (2) Based on— collection, research, establishment of user fee. HHS/CDC will impose the fee (A) The costs to the Government; standards, and regulation. Full costs are by schedule and will notify importers of (B) The value of the service or thing determined based on the best available changes to the user fee by notice in the to the recipient; records of the agency. Federal Register. Importers may also (C) Public-policy or interest served; Agencies are responsible for the contact HHS/CDC at 404–498–1600 or and initiation and adoption of user charge check its Web site (http://www.cdc.gov/ (D) Other relevant facts. schedules consistent with the guidance animalimportation/) for an up-to-date OMB Circular A–25 (‘‘the Circular’’) listed in the Circular. In doing so, fee schedule. establishes general policy for agencies should identify the services In its analysis of cost, HHS/CDC implementing user fees, including and activities covered by the Circular; considered five components: (1) The criteria for determining amounts and determine the extent of the special cost of reagents and materials; (2) the exceptions, and guidelines for benefits provided; and apply the cost of the BSL–4 laboratory in reagent implementation. According to the principles set forth in the Circular in production and during the assay; (3) the Circular, its provisions must be applied determining full cost or market cost as cost of irradiation of the sample; (4) to any fees collected pursuant to the appropriate. personnel costs to perform the testing; IOAA authority. Finally, CDC has legal authority to and (5) administrative costs. The total The Circular states that ‘‘[a] user retain collected user fees through its cost to the Government is summarized charge annual appropriations bill. In fiscal year in Table 1 followed by a description of * * * will be assessed against each 2012, this authority is provided through each component; all monies reflected identifiable recipient for special benefits the Consolidated Appropriations Act of are in U.S. Dollars (USD).

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TABLE 1—SUMMARY CALCULATIONS hazard pathogens. Safety restrictions on Total cost: Adding these parts (Table OF USER FEE CHARGE-PER-TEST irradiators are complex and time 1) results in a grand total of $540. We consuming; requiring frequent, note that our results can potentially vary professional safety inspections and from this figure for a couple of reasons. Components Costs (USD) complex annual training for all First, as mentioned already, commercial personnel that work with or near the data are not available for some of the 1. Use of reagents and other mate- irradiator. Finally, a high level of reagents so our calculation of their costs rials ...... $100 2. Use of BSL–4 lab facility ...... 112 security must be maintained because the is an estimate and not based on 3. Irradiation (inactivation) of sample 150 complexities of using irradiators and the observed market pricing. Second, the 4. Personnel costs to conduct testing 145 specimens being irradiated require costs will vary depending on how many 5. Administrative costs ...... 33 access to be controlled and monitored. tests are conducted at one time. If Typically it takes five hours to multiple tests are run concurrently, then ESTIMATED TOTAL ...... 540 inactivate a sample, at a total estimated the costs would be a bit less. If only one User Fee ...... 540 irradiation cost of $150. test is conducted at one time, the costs will be relatively higher. Therefore, we The first component in the estimate is The fourth component of the cost is set the cost of reimbursement per test at the cost of the reagent materials and the hourly wage and benefits of $540. We feel confident that this is a fair other materials necessary to perform the personnel who perform the laboratory price to the importers because this test. Two reagents are used to prepare tests. We assume that the scientist the specific antibodies needed in the performing the test is a microbiologist amount is consistent with the sum test. These reagents are not with a masters’ degree. Most of the charged by the commercial lab of commercially available and must be personnel in this category are paid at a $500.00 that previously performed these made in-house by HHS/CDC scientists. GS 11 level. For the purposes of this tests. We also note that our assumption Since these reagents are not estimate, we have assumed a pay level of the effect of multiple tests is commercially available, there is no of GS 11, Step 3. We set the basic wage supported by past experience. HHS/CDC commercial or observable product at $25.70 per hour, and a benefit of 30% receives notification of about 100 to 150 pricing. HHS/CDC estimates the cost for for a total hourly salary of $33.41 an requests performed per year. Although these reagents to be $70.00. This amount hour (U.S. Office of Personnel HHS/CDC cannot control the flow of includes the cost of production and Management 2010 General Schedule tests and cannot forecast how many validation of the reagents. Material costs (GS) Locality Pay Tables for Atlanta; tests will be underway at any given include plastic plates, pipettes, and http://www.opm.gov/oca/11tables/ point in time, HHS/CDC estimates that other reagents. These items are available indexgs.asp). In total, the tests take the total amount of fees charged will commercially and their cost is estimated about 13 hours (four hours in the BSL– range from about $50,000 to $75,000 per at $30.00. Thus, the total estimated cost 4; three hours of irradiation; and six year. The user fee charged for the testing for this component totals $100.00 per hours running the test with will cover the costs of the test. test. This cost can be a bit higher or interpretation). However, we assume HHS/CDC will impose the user fee by lower depending on how many tests are that the person working on this test will schedule. An up-to-date fee schedule is run at the same time. If the test requests be carrying on other duties available from the Division of Global come in one at a time, then the cost simultaneously. Therefore, we assign Migration & Quarantine, Centers for might be above $100, if there is more one-third of the 13 hours of work time Disease Control and Prevention, 1600 than one request at a time, the cost to the fourth part, or $145.00 ($434.33/ Clifton Road, Atlanta, Georgia 30333, might be a bit less than $100. The test 3). 404–498–1600, or [insert url of Web calls for the same amount of reagents for The fifth and final component is the site]. one or 3 samples to test. administrative costs related to test result VII. Payment Instructions The second component is the cost of collection and dissemination. The the BSL–4 facility that is used to individual responsible for the activities HHS/CDC Importers should submit a develop the reagents. We have estimated under this component is typically in a check or money order in the amount of this cost on the charges made by supervisory position. The supervisor $540.00 (USD) made payable to Centers University of Texas Medical Branch at examines the assay to ensure that the for Disease Control and Prevention for Galveston (UTMB) of $28 per hour. The positive and negative tests (quality each test conducted at the time that UTMB is the only BSL–4 facility in the controls) are accurate, and to ensure that specimens are submitted to the CDC for United States that has developed the test was performed according to testing. The check(s) should be sent to commercial fees for the use of their labs. prescribed scientific standards. The Centers for Disease Control and In the ELISA methodology, scientists supervisor puts the results on a Prevention, P.O. Box 15580, Atlanta, GA need four hours in the BSL–4 laboratory response form and sends the results to 30333. to process the sample. The cost of this the importer with a copy to CDC’s VIII. Regulatory Analyses component is $112.00. Division of Global Migration and The third component in the cost Quarantine (DGMQ). To calculate this A. Required Regulatory Analyses under estimate is the cost to inactivate the cost, we used half an hour of the salary Executive Orders 12866 and 13563 sample by irradiation in an irradiator. and benefits of a GS 14 level, Senior We have examined the impacts of the For this component, we estimate the Health Scientist (601 series). The hourly direct final rule under Executive Orders cost to use an irradiator at $30 per hour. rate of a GS14, level 3 is $50 (U.S. Office 12866 and 13563, which direct agencies This estimate is based on a five-year of Personnel Management 2010 General to assess all costs and benefits of cost of $300,000 to HHS/CDC to run and Schedule (GS) Locality Pay Tables for available regulatory alternatives and, maintain the irradiator. Irradiators are Atlanta; http://www.opm.gov/oca/ when regulation is necessary, to select extremely expensive to maintain for a 10tables/indexgs.asp). We added 30% of regulatory approaches that maximize number of reasons. Only research the hourly rate for benefits to total net benefits (including potential facilities have irradiator equipment $65.00. Thirty minutes of this economic, environmental, public health because of the need to inactivate high- individual’s time is $33.00. and safety, and other advantages,

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distributive impacts, and equity). E. National Environmental Policy Act Transit and Quarantine. Morbidity and Because the purpose of this rule is to (NEPA) Mortality Weekly Report MMWR 1990; provide a framework to determine a fair 39(2):22–24, 29–30. Pursuant to 48 FR 9374 (list of HHS/ 2. Roper, W.L. Dear interested party (letter). fee to charge for a service that has CDC program actions that are March 15, 1990. Available upon request: become unavailable in private, categorically excluded from the NEPA (404) 639–1600. commercial markets within the United environmental review process), HHS/ 3. 55 FR 10288, March 20, 1990, States, we have determined that the rule CDC has determined that this action ‘‘Importation of Nonhuman Primates: will not violate the intent of either of does not qualify for a categorical Meeting.’’ the Executive Orders because it will in exclusion. In the absence of an 4. Centers for Disease Control and Prevention. Update: Filovirus Infection no way prevent a private entity from applicable categorical exclusion, the in Animal Handlers. Morbidity and entering the field and providing a Director, CDC, has determined that Mortality Weekly Report MMWR 1990; similar, privatized service. If any private provisions amending 42 CFR 71.53 will 39(13):221. entity expresses an interest in providing not have a significant impact on the 5. 55 FR 15210, April 20, 1990, Requirement this service, we will strongly encourage human environment. Therefore, neither for a Special-permit to Import them to do so. an environmental assessment nor an Cynomolgus, African Green, or rhesus environmental impact statement is Monkeys into the United States. B. Regulatory Flexibility Act required. 6. Roper, W.L. Dear interested party (letter). October 10, 1991. Available upon We have examined the impacts of the F. Civil Justice Reform (Executive Order request: (404) 639–1600. direct final rule under the Regulatory 12988) 7. Ksiazek, Thomas G.; Rollin, Pierre E.; Jahrling, Peter B.; Johnson, Eugene; Flexibility Act (5 U.S.C. 601–612). This direct final rule has been Unless we certify that the rule is not Dalgard, Dan W., and Peters, Clarence J. reviewed under Executive Order 12988, Enzyme immunosorbent assay for Ebola expected to have a significant economic Civil Justice Reform. Under this direct virus antigens in tissues of infected impact on a substantial number of small final rule: (1) All State and local laws primates. Journal of Clinical entities, the Regulatory Flexibility Act, and regulations that are inconsistent Microbiology. 1992; 30(4):947–950. as amended by the Small Business with this rule will be preempted; (2) no 8. Ksiazek, Thomas G. Laboratory diagnosis Regulatory Enforcement Fairness Act retroactive effect will be given to this of filovirus infections in nonhuman (SBREFA), requires agencies to analyze primates. Laboratory Animal. 1991; rule; and (3) administrative proceedings 20(7):34–46. regulatory options that would minimize will not be required before parties may 9. Tipple, M.A. Dear interested party (letter). any significant economic impact of a file suit in court challenging this rule. March 5, 1996. Available upon request: rule on small entities. We certify that (404) 639–1600. this rule will not have a significant G. Executive Order 13132 (Federalism) 10. Demarcus, T., Tipple, M., Ostrowski, S., economic impact on a substantial The Department has reviewed this US Policy for Disease Control among number of small entities within the rule in accordance with Executive Order Imported Nonhuman Primates, J Infect meaning of the RFA. 13132 regarding federalism, and has Dis. (1999) 179 (supplement 1): S281– determined that it does not have S282. C. Small Business Regulatory ‘‘federalism implications.’’ The rule List of Subjects in 42 CFR Part 71 Enforcement Fairness Act of 1996 does not ‘‘have substantial direct effects Communicable diseases, Public This regulatory action is not a major on the States, on the relationship health, Quarantine, Reporting and rule as defined by Sec. 804 of the Small between the national government and recordkeeping requirements, Testing, Business Regulatory Enforcement the States, or on the distribution of User fees. power and responsibilities among the Fairness Act of 1996. This direct final For the reasons set forth in the various levels of government.’’ rule will not result in an annual effect preamble, amend 42 CFR part 71 as on the economy of $100,000,000 or H. Plain Language Act of 2010 follows: more; a major increase in cost or prices; Under Public Law 111–274 (October PART 71—FOREIGN QUARANTINE or significant adverse effects on 13, 2010), executive Departments and competition, employment, investment, Agencies are required to use plain ■ 1. The authority citation for part 71 productivity, innovation, or on the language in documents that explain to continues to read as follows: ability of United States-based the public how to comply with a Authority: Secs. 215 and 311 of the Public companies to compete with foreign- requirement the Federal Government based companies in domestic and Health Service (PHS) Act, as amended (42 administers or enforces. HHS has U.S.C. 216, 243); section 361–369, PHS Act, export markets. attempted to use plain language in as amended (42 U.S.C. 264–272); 31 U.S.C. D. The Paperwork Reduction Act of promulgating this rule consistent with 9701. 1995 the Federal Plain Writing Act guidelines. Subpart F—Importations HHS/CDC has reviewed the I. Conclusion ■ 2. In § 71.53, add paragraph (j) to read information collection requirements of as follows: the direct final rule and has determined In accordance with the provisions of that the information collection Executive Order 12866, this direct final § 71.53 Nonhuman primates. requested in the direct final rule is rule was not reviewed by the Office of Management and Budget. * * * * * already approved by the Office of (j) Filovirus testing fee. (1) Effective Management and Budget (OMB) under IX. References March 12, 2012, non-human primate OMB Control No. 0920–0263, expiration 1. Centers for Disease Control and importers shall be charged a fee for date 6/30/2014. The direct final rule Prevention. Update: Ebola-Related filovirus testing of non-human primate does not contain any new data Filovirus Infection in Nonhuman liver samples submitted to the Centers collection or record keeping Primates and Interim Guidelines for for Disease Control and Prevention requirements. Handling Nonhuman Primates during (CDC).

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(2) The fee shall be based on the cost adopt or to show evidence of being modified BFEs are made final in the of reagents and other materials already in effect in order to qualify or communities listed below. Elevations at necessary to perform the testing; the use remain qualified for participation in the selected locations in each community of the laboratory testing facility; National Flood Insurance Program are shown. irradiation for inactivation of the (NFIP). National Environmental Policy Act. sample; personnel costs associated with DATES: The date of issuance of the Flood This final rule is categorically excluded performance of the laboratory tests; and Insurance Rate Map (FIRM) showing from the requirements of 44 CFR part administrative costs for test planning, BFEs and modified BFEs for each 10, Environmental Consideration. An review of assay results, and community. This date may be obtained environmental impact assessment has dissemination of test results. by contacting the office where the maps not been prepared. (3) An up-to-date fee schedule is are available for inspection as indicated Regulatory Flexibility Act. As flood available from the Division of Global in the table below. elevation determinations are not within Migration & Quarantine, Centers for ADDRESSES: The final BFEs for each the scope of the Regulatory Flexibility Disease Control and Prevention, 1600 community are available for inspection Act, 5 U.S.C. 601–612, a regulatory Clifton Road, Atlanta, Georgia 30333. at the office of the Chief Executive flexibility analysis is not required. Any changes in the fee schedule will be Officer of each community. The Regulatory Classification. This final published in the Federal Register. respective addresses are listed in the rule is not a significant regulatory action (4) The fee must be paid in U.S. table below. under the criteria of section 3(f) of dollars at the time that the importer FOR FURTHER INFORMATION CONTACT: Luis Executive Order 12866 of September 30, submits the specimens to HHS/CDC for Rodriguez, Chief, Engineering 1993, Regulatory Planning and Review, testing. Management Branch, Federal Insurance 58 FR 51735. Dated: January 19, 2012. and Mitigation Administration, Federal Executive Order 13132, Federalism. Kathleen Sebelius, Emergency Management Agency, 500 C This final rule involves no policies that Secretary. Street SW., Washington, DC 20472, have federalism implications under [FR Doc. 2012–2843 Filed 2–9–12; 8:45 am] (202) 646–4064, or (email) Executive Order 13132. BILLING CODE 4163–18–P [email protected]. Executive Order 12988, Civil Justice SUPPLEMENTARY INFORMATION: The Reform. This final rule meets the Federal Emergency Management Agency applicable standards of Executive Order DEPARTMENT OF HOMELAND (FEMA) makes the final determinations 12988. SECURITY listed below for the modified BFEs for List of Subjects in 44 CFR Part 67 each community listed. These modified Federal Emergency Management elevations have been published in Administrative practice and Agency newspapers of local circulation and procedure, Flood insurance, Reporting ninety (90) days have elapsed since that and recordkeeping requirements. 44 CFR Part 67 publication. The Deputy Federal Accordingly, 44 CFR part 67 is [Docket ID FEMA–2011–0002] Insurance and Mitigation Administrator amended as follows: has resolved any appeals resulting from Final Flood Elevation Determinations this notification. PART 67—[AMENDED] This final rule is issued in accordance AGENCY: Federal Emergency with section 110 of the Flood Disaster ■ 1. The authority citation for part 67 Management Agency, DHS. Protection Act of 1973, 42 U.S.C. 4104, continues to read as follows: ACTION: Final rule. and 44 CFR part 67. FEMA has Authority: 42 U.S.C. 4001 et seq.; developed criteria for floodplain Reorganization Plan No. 3 of 1978, 3 CFR, SUMMARY: Base (1% annual-chance) management in floodprone areas in 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, Flood Elevations (BFEs) and modified accordance with 44 CFR part 60. 3 CFR, 1979 Comp., p. 376. BFEs are made final for the Interested lessees and owners of real § 67.11 [Amended] communities listed below. The BFEs property are encouraged to review the and modified BFEs are the basis for the proof Flood Insurance Study and FIRM ■ 2. The tables published under the floodplain management measures that available at the address cited below for authority of § 67.11 are amended as each community is required either to each community. The BFEs and follows:

* Elevation in feet (NGVD) + Elevation in feet (NAVD) Flooding source(s) Location of referenced elevation # Depth in feet Communities above ground affected ∧ Elevation in me- ters (MSL) Modified

Humphreys County, Mississippi, and Incorporated Areas Docket No.: FEMA–B–1159

Shallow Flooding ...... An area bounded by the county boundary to the west and +100 Unincorporated Areas of south, the William M. Whittington Channel Levee to the Humphreys County east, and the confluence with Silver Creek and Straight Bayou to the north. Yazoo River ...... Approximately 10 miles upstream of State Highway 12 ..... +117 Unincorporated Areas of Humphreys County.

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